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Drug Facts
Distributed by:
Kenvue Brands LLC
Summit, NJ 07901
Tylenol Precise Pain Relieving Lidocaine 4% Patch
FDA Label NDC 69968-0927
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Tylenol Precise Pain Relieving Lidocaine 4% (NDC 69968-0927). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Lidocaine 4%
Otc - Purpose
Purpose
Topical Analgesic
Uses
For the temporary relief of pain
Warnings
For external use only.
Otc - Do Not Use
Do not use
- more than one patch at a time
- on wounds or damaged skin
- on raw surfaces or blistered areas
- with a heating pad
Otc - When Using
When using this product
- avoid contact with eyes or mucous membranes
- do not bandage tightly
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens or symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
- excessive skin irritation occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If put in mouth or swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
adults and children 12 years of age and older:
children 12 to under 18 years of age, use with adult supervision
- apply contents of one pouch to affected area not more than 3 to 4 times daily
- remove a patch after at most 12 hours
- single-use patch. Do not reapply
- fold used patches so that the adhesive side sticks to itself and safely discard where children cannot get to them
children under 12 years of age: do not use
Other Information
Store at 20°C to 25°C (68°F - 77°F) ■ Open pouches are not child resistant.
Inactive Ingredients
diacetone acrylamide - acrylamidomethylpropane sulfonic acid copolymer, diethylene glycol monoethyl ether, ethylparaben, glycerin, isopropyl laurate, methylparaben, polysorbate 80, povidone, propylene glycol, water, sodium hydroxide
Questions Or Comments?
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
Principal Display Panel - Tylenol Patch Label
NEW
TYLENOL ®
PRECISE TM
Pain Relieving Patch
Lidocaine 4% Topical Analgesic
Targeted penetrating pain relief
12
Stays on for
up to 12 hours
Designed with
specialized
adhesion
technology
Maximum
Strength
Lidocaine without
a prescription
4 INDIVIDUALLY SEALED PATCHES
3.3 in X 4.4 in (8.3 cm X 11.1 cm)
See back of carton for actual size
UNSCENTED
FOR EXTERNAL USE ONLY
Tylenol_1 (Tylenol 1)
* Please review the disclaimer below.
